LEXIVA fosamprenavir calcium tablet film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FOSAMPRENAVIR CALCIUM (UNII: ID1GU2627N) (AMPRENAVIR - UNII:5S0W860XNR)

Sẵn có từ:

Avera McKennan Hospital

INN (Tên quốc tế):

FOSAMPRENAVIR CALCIUM

Thành phần:

FOSAMPRENAVIR 700 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

LEXIVA- FOSAMPRENAVIR CALCIUM TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEXIVA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEXIVA.
LEXIVA (FOSAMPRENAVIR CALCIUM) TABLETS, FOR ORAL USE
LEXIVA (FOSAMPRENAVIR CALCIUM) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Contraindications (4)
09/2016
INDICATIONS AND USAGE
LEXIVA is an HIV protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-1
infection. (1)
DOSAGE AND ADMINISTRATION
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Dosing Considerations
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Therapy-naive Adults: LEXIVA 1,400 mg twice daily; LEXIVA 1,400 mg
once daily plus ritonavir 200 mg once daily;
LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily; LEXIVA
700 mg twice daily plus ritonavir 100 mg
twice daily. (2.1)
Protease Inhibitor-experienced Adults: LEXIVA 700 mg twice daily plus
ritonavir 100 mg twice daily. (2.1)
Pediatric Patients (aged at least 4 weeks to 18 years): Dosage should
be calculated based on body weight (kg) and
should not exceed adult dose. (2.2)
Hepatic Impairment: Recommended adjustments for patients with mild,
moderate, or severe hepatic impairment.
(2.3)
LEXIVA tablets may be taken with or without food. (2)
LEXIVA suspension: Adults should take without food; pediatric patients
should take with food. (2)
700-mg tablets (3)
50-mg-per-mL oral suspension (3)
Hypersensitivity to LEXIVA or amprenavir (e.g., Stevens-Johnson
syndrome). (4)
Drugs highly dependent on CYP3A4 for clearance and for which elevated
plasma levels may result in serious and/or
life-threatening events. (4)
Review ritonavir contraindications when used in combination. (4)
The concomitant use of LEXIVA with ritonavir and certain other drugs
may result in known or potentially significant
drug interactions. Consult the full pres